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Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU

The Q1/24 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy.Key new developments: Pharma: EC ...

News

CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

News

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

Insights and Analysis

Hogan Lovells 2024 M&A Outlook

Our 10th annual M&A Year in Review features a 2024 M&A Outlook, which provides insights across the key topics that we expect will influence dealmaking in the months to come:...

News

The use of IVDs as CDx in pharmaceutical clinical trials

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for...

News

HRSA issues 340B Program final rule modifying administrative dispute resolution process

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative ...

News

2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

News

Reduction of EU regulatory data protection, but not as short as the European Commission proposed

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as...

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New Commission Action Plan to boost biotechnology and biomanufacturing in the EU

Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic ...

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